Clofarabine Plus Low-Dose Cytarabine Induction Followed by Consolidation of Clofarabine Plus Low-Dose Cytarabine Alternating With Decitabine in Frontline Acute Myeloid Leukemia (AML) and High-Risk Myelodysplastic Syndrome (MDS)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 122
- 试验地点
- 1
- 主要终点
- Disease-free (DFS) or Relapse-free Survival (RFS) Time
研究概览
简要总结
The goal of this clinical research study is to learn if clofarabine given in combination with cytarabine and decitabine can help to control the disease in patients with AML or MDS who are 60 years old or older. The safety of this treatment will also be studied.
详细描述
The Study Drugs:
Clofarabine is designed to interfere with the growth and development of cancer cells.
Cytarabine is designed to insert itself into DNA (the genetic material of cells) of cancer cells and stop the DNA from repairing itself.
Decitabine is designed to damage the DNA of cells, which may cause cancer cells to die.
Study Drug Administration:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Previously untreated AML and high-risk MDS (>/= 10% blasts or >/= IPSS intermediate-2). Prior therapy with hydroxyurea, biological or targeted therapy (e.g. flt3 inhibitors, other kinase inhibitors, azacitidine), or hematopoietic growth factors is allowed.
- •Age >/= 60 years.
- •Eastern Cooperative Oncology Group (ECOG) performance status </=
- •Adequate hepatic (serum total bilirubin </= 1.5 x ULN, serum glutamate pyruvate transaminase (SGPT) and/or serum glutamate oxaloacetate transaminase (SGOT) </= 2.5 x ULN) and renal function (creatinine </= 1.5 mg/dL).
- •Sign written informed consent
排除标准
- •Cardiac ejection fraction < 40%.
- •Prior therapy with clofarabine or decitabine.
- •Active and uncontrolled disease/infection as judged by the treating physician.
- •Acute promyelocytic leukemia (APL).
- •Women of childbearing potential and men who do not practice contraception.
- •Women of childbearing potential and men must agree to use contraception prior to study entry and for the duration of study participation.
研究组 & 干预措施
Clofarabine + Cytarabine + Decitabine
Clofarabine 20 mg/m^2 by vein (IV) as a 1- to 2-hour intravenous infusion daily for 5 days. Cytarabine 20 mg subcutaneously twice daily for 10 days, administered 3 to 6 hours following the start of the clofarabine infusions. Decitabine 20 mg/m^2 as a 1- to 2-hour infusion daily for 5 days.
干预措施: Clofarabine (Drug)
Clofarabine + Cytarabine + Decitabine
Clofarabine 20 mg/m^2 by vein (IV) as a 1- to 2-hour intravenous infusion daily for 5 days. Cytarabine 20 mg subcutaneously twice daily for 10 days, administered 3 to 6 hours following the start of the clofarabine infusions. Decitabine 20 mg/m^2 as a 1- to 2-hour infusion daily for 5 days.
干预措施: Cytarabine (Drug)
Clofarabine + Cytarabine + Decitabine
Clofarabine 20 mg/m^2 by vein (IV) as a 1- to 2-hour intravenous infusion daily for 5 days. Cytarabine 20 mg subcutaneously twice daily for 10 days, administered 3 to 6 hours following the start of the clofarabine infusions. Decitabine 20 mg/m^2 as a 1- to 2-hour infusion daily for 5 days.
干预措施: Decitabine (Drug)
结局指标
主要结局
Disease-free (DFS) or Relapse-free Survival (RFS) Time
时间窗: Evaluated from treatment date until date of disease progression/relapse, followed for 5 years/60 months.
Disease (DFS) or Relapse-free survival (RFS): Time from date of treatment start until the date of first objective documentation of disease-relapse; Bone marrow aspirate and/or biopsy starting on day 21 (+/- 7 days) of therapy and then every 2 weeks (+/- 7 days) as required by leukemia evolution until remission or non-response. Among participants who achieved CR or CRp, RFS was defined as the time interval between the date of response (ie CR or CRp) and the date of relapse or date of death, whichever occurs first. CR or CRp participants who were alive and relapse-free were censored at the off-study date. Full range reflects time to disease progression only, therefore does not reflect a lesser survival time due to other reasons than disease progression/relapse.
Complete Remission (CR) Rate for First 60 Participants
时间窗: Evaluation following two 10 day cycles on day 21 of therapy, continuing up to 210 days
All responses were defined as per IWG criteria (2003) where CR Rate defined as number of participants with CR out of total treated participants. Complete remission (CR): Disappearance of all clinical and/or radiologic evidence of disease. Neutrophil count \> 1.0 times 10\^9/L and platelet count \> 100 times 10\^9/L, and normal bone marrow differential (\< 5% blasts). Bone marrow aspirate and/or biopsy starting on day 21 (+/- 7 days) of therapy.
Median Overall Survival (OS)
时间窗: Evaluated from treatment date until date of death, followed for 5 years/60 months.
Overall survival (OS): Time from date of treatment start until date of death due to any cause.
Number of Participants With Complete Remission [Complete Response (CR), Complete Response With Platelet Recover (CRp) or Complete Response With Incomplete Marrow Recovery (CRi)]
时间窗: Beginning assessment following two 10-day induction cycles through an additional re-induction cycle, up to 40 days
All responses were defined as per IWG criteria (2003) where CR Rate defined as number of participants with CR out of total treated participants. Complete remission (CR): Disappearance of all clinical and/or radiologic evidence of disease. Neutrophil count \> 1.0 times 10\^9/L and platelet count \> 100 times 10\^9/L, and normal bone marrow differential (\< 5% blasts). Complete response with incomplete marrow recovery (CRi), defined as CR above, but without normal blood counts. Bone marrow aspirate and/or biopsy starting on day 21 (+/- 7 days) of therapy.
次要结局
- Event Free Survival (EFS)(Follow up up to 5 years/60 months.)
- Overall Response Rate (CR, CRp/CRi and PR)(Beginning assessment following two 10-day induction cycles through an additional re-induction cycle, up to 40 days)